The Med­ical Device Coor­di­na­tion Group (MDCG) has pub­lished guid­ance MDCG 2021-21 “Guid­ance on per­for­mance eval­u­a­tion of SARS-CoV-2 in vit­ro diag­nos­tic med­ical devices” – the doc­u­ment is crit­i­cal for all man­u­fac­tur­ers who man­u­fac­ture and have CE marked COVID-19 tests under the IVD Direc­tive (IVDD). 

More specif­i­cal­ly, the spec­i­fies aspects like sam­ple sizes, accep­tance cri­te­ria and oth­er crit­i­cal points for the device per­for­mance evaluation.

In this con­text, the guid­ance doc­u­ment dif­fer­en­ti­ates between first line assays, confirmatory/ sup­ple­men­tary assays and oth­er cat­e­gories. Fur­ther­more, MDCG 2021-21 empha­sizes the impor­tance of the state of the art.
It states that the per­for­mance eval­u­a­tion should be car­ried out in direct com­par­i­son to a CE marked state of the art test. In addi­tion, per­for­mance eval­u­a­tions should be con­duct­ed on a pop­u­la­tion that is equiv­a­lent to the Euro­pean population. 

Fur­ther direc­tion is pro­vid­ed on con­sid­er­a­tions regard­ing sensitivity/ speci­fici­ty, interference/ cross reac­tiv­i­ty and batch testing.

Man­u­fac­tur­ers are request­ed to care­ful­ly review the doc­u­ment and make sure that the cor­re­spond­ing require­ments are ful­filled. If not ful­filled, val­i­da­tion relat­ed to the per­for­mance eval­u­a­tion should be cor­rect­ed as soon as pos­si­ble. Com­pe­tent author­i­ties may con­duct tech­ni­cal doc­u­men­ta­tion audits and require prod­uct de-reg­is­tra­tions if the require­ments have not been met.

MDCG 2021-21 also says that “the con­tent of this guid­ance doc­u­ment is envis­aged to form the basis for com­mon spec­i­fi­ca­tions to be adopt­ed accord­ing to Arti­cle 9 of Reg­u­la­tion (EU) 2017/746 in the com­ing months.”

So the guid­ance is cru­cial also for ful­fill­ing the com­ing IVDR require­ments, which will become applic­a­ble as of May 26, 2022.

Please let us know should you wish mdi Europa to pro­vide you with the guid­ance document.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing arti­cles on our website